Latest Drugwonks' Blog
If it’s unlikely that Washington will pass meaningful health care reform any time soon. Yet health care costs are still exploding — making quality care unaffordable for too many Americans and putting a financial burden on us all.
Surprisingly, though, there’s a smart move that health insurers can make that will lower costs for consumers and insurers alike, and improve patient health: Reduce co-pays on prescription drugs.
High drug prices lead many Americans to skip doses or quit prescriptions entirely. Yet prescription drug prices aren’t rising — it’s patients’ out-of-pocket costs, or co-pays. Over the past several years, insurance companies have become increasingly reluctant to foot the bill for brand-name medications. Indeed, since 2000, co-pays have increased four times faster than prescription drug prices.
Patients respond to higher co-pays by skipping their meds more often. In 2003, researchers at the University of Oregon studied the effects of introducing a $2 to $3 co-pay for prescription meds among 17,000 patients. Adherence to treatment dropped by 17 percent.
Some insurers are even refusing to cover new prescription drugs. According to a study from Wolter Kluwer Health, insurers’ denial rate for brand-name meds was 10.8 percent at the end of 2008 — a 21 percent jump from the year before.
Abandoning treatment — a practice known as "non-adherence” — has serious consequences for patient health. For instance, people with hypertension who neglect their meds are more than five times more likely to experience a poor clinical outcome than those who don’t. Heart disease patients are 1.5 times more likely.
It also results in higher medical costs, as patients who go off their meds often end up in the hospital. Minor conditions that might have been controlled by inexpensive medications can sometimes balloon into life-threatening illnesses that require surgery or other costly treatments.
This makes sense. After all, a daily cholesterol-lowering drug is far less expensive than emergency heart surgery.
As Congress figures out what to do next on health care reform, private insurers can act now to control their own costs and vastly improve medical outcomes, all while making health care more affordable for average Americans. Reducing drug co-pays is the way to do it.
Last week, over-ruling a lower court and obvious logic, a New Jersey appeals court ruled that a trial court should reconsider allowing a so-called “expert” to testify in Palazzolo v. Hoffman La Roche, Inc, a lawsuit alleging that Accutane causes depression. The issue involves whether an expert should be allowed to offer testimony on a study that was (1) considered flawed and (2) was funded by plaintiffs and lawyers involved in the litigation.
The trial court in New Jersey ruled that Doug Bremner, an Emory University professor, should not be allowed to offer expert testimony on his “flawed study.” Now the appeals court has remanded the case to the trial court "to consider whether Bremner should be allowed to testify on causation, without reference to the study.” (The trial judge decided the study was central to his opinion and dismissed the case.)
To quote that well-known legal expert, Madonna – not!
There are two main problems, one scientific and other ethical. Problem #1 is Bremner’s reliance on PET scans to find metabolic changes in the brains of acne patients treated with Accutane (the problem being that all parties agreed that that PET scans could not diagnose depression). The second, as already mentioned, is that Bremner’s study was commissioned specifically for use in the litigation by plaintiffs and lawyers involved in the litigation.
Can you imagine the hue and cry if a pharmaceutical company had done this? Since sunshine is always the most potent disinfectant, how about a Sunshine Act for the tort bar?
To quote the English social reformer, William Ellery Channing, “It is far more important to me to preserve an unblemished conscience than to compass any object however great.”
By doing so Clinton and his doctors flouted the conclusion of what the WSJ's Keith Winstein's lovingly calls "a simple concept: Study different medical treatments and figure out which delivers the best results at the cheapest cost, giving patients the most effective care."
That comparative effectiveness research. And Winstein is the muse to those who insist that people like the former POTUS should been given old drugs for 4 months rather than having a stent procedure:
"Even before Congress took up the now-stalled health-care overhaul, it appropriated $1.1 billion to fund these studies. Both the Senate and the House included it in their versions of the bill. President Barack Obama backed it.
Yet, an examination of one of the best-known examples of a comparative-effectiveness analysis shows how complicated such a seemingly straightforward idea can get.
The study, known as "Courage" and published in the New England Journal of Medicine in 2007, shook the world of cardiology. It found that the most common heart surgery—a $15,000 procedure that unclogs arteries using a small scaffold or stent—usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain.
The Courage trial was led by William Boden, a Buffalo, N.Y., cardiologist, and funded largely by the Department of Veterans Affairs. It tracked 2,287 patients for five years and found that trying drugs first, and adding stents only if chest pain persisted, didn't affect the rate of deaths and heart attacks, although stents did produce quicker pain relief."
http://online.wsj.com/article/SB10001424052748703652104574652401818092212.html?KEYWORDS=stents
But what did this study really say? And should one study shape how every doctor treats every patient?
Winstein ignores the fact that even the COURAGE study shows that 1 in 4 patients with chest pain need a stent and drugs to survive as long as others who just received drugs. And it ignores the fact that the tools in the study used to identify which patients would benefit most from specific clot busting approaches and medicines -- a PET stress test and gene test for drug response -- are not widely reimbursed yet because they have not undergone the same kind of comparative effectivenesss research your article swoons over. In otherwords, it's ok to use new technologies to make the case not to pay doctors, but not to pay for those technologies when doctors want to use them. That is comparative effectiveness simply put.
Even worse, when quoting Eric Topol in the article Winstein makes it seem that Topol is in favor of the one size fits all approach:
It's certainly remarkable that nothing has been done to put some checks and balances," into the stenting decision after Courage, says Eric Topol, the chief academic officer of Scripps Health, a hospital operator in San Diego. "I have a very strong disagreement with cardiologists who see no reason to do the stress test."
Winstein fails to note what he likely knew if he interview Topol at length, that Topol is also doing gene-testing prior to drug selection for eluting PCI and is a leader in personalized medicine in cardiology.
But that didn't fit the narrative that one study can decide what treatment is good in all cases vs the judgment of doctors and their clinical experience.
Good thing Clinton's doctors didn't drink the COURAGE kool-aid. In the future it would be an act of leadership and consistency for all supporters of CER and its methods to ask their doctors to treat them according what CER studies supported by the government say. Their could even be a health plan for such people. Keith should be the first enrollee.
By Jacob Goldstein
Now that it’s expanded health-insurance coverage to nearly all of its citizens, Massachusetts is trying to figure out what to do about the rapid rise of health costs.
The latest proposal comes from the state’s governor, Deval Patrick, who yesterday proposed a bill that would give the state the power to review — and, in some cases, reject — rate increases by doctors and hospitals.
Here’s a key paragraph from the bill:
Any contract under which provider payments increase by an amount in excess of the applicable Consumer Price Index for Medical Care Services shall be presumptively disapproved. The division may conduct a hearing on any contract that is presumptively disapproved and will approve or disapprove the contract based on its findings following the hearing.
The bill would also allow the state to prevent health-insurance plans sold to small businesses from raising premiums by more than 1.5 times the rate of medical inflation, and impose a two-year moratorium on lawmakers mandating new health benefits that plans must cover (those mandates drive up costs).
The Boston Globe said reaction “was mixed, with small business groups expressing cautious optimism, insurers saying the measures do not go far enough, and health care providers worrying that smaller hospitals could be disproportionately harmed and that some might have to lay off caregivers.”
http://blogs.wsj.com/health/2010/02/11/mass-governor-wants-to-cap-hospital-doctor-rate-increases/
Mixed? I wonder what insurers will say when their rates are capped. In any event, price controls will only worsen the shortage of primary care in the Bay State and reduce the availability of services.
Here is something else Republicans can bring up in their summit: Government regulation of health care reduces employment and investment..
According to that blog:
“Medicine is fraught with ethical dilemmas. The very nature of health care, medicine and biology offer insights into humanity. Additionally, issues of medical ethics delves into the most intimate parts of our lives, focusing on our bodies — sometimes at a cellular level. The state of health care, and the technology that is coming to medicine offer new challenges to the idea of what is right and wrong. Here are 50 medical ethics blogs that can offer insight on the debate.”
We are pleased to be in such esteemed company.
The complete list can be found here.
(See, life really does begin at 50.)
"Meanwhile, supporters have spent most of their time on seemingly endless debates with one another about specific legislative provisions — whether to include a public option in the reform legislation, whether to have a single national insurance exchange or separate state exchanges, how to enforce a mandate that everyone carry insurance and how much to spend on subsidies to make that mandate acceptable, how to enforce a mandate on all but small employers to sponsor and pay for basic coverage for their workers, and scores of other complex and bewildering technical provisions.
Health care reformers in the administration and Congress have a powerful case to make and, on an issue of such enormous importance, a duty to make it. In addition to reminding Americans that reform will protect, not jeopardize, coverage by preventing insurance companies from canceling coverage or jacking up premiums for the sick, reform advocates should remind them that the proposed legislation will bring coverage to tens of millions of currently uninsured Americans and protect it for scores of millions of others. Reform advocates should explain the legislation’s legitimate promise of cost control and quality improvement.
President Barack Obama has announced a bipartisan meeting on moving the reform process forward. It is an opportunity for all sides to present ideas for improving the bills that already have been passed by both houses of Congress. If modifications are identified that will command the support of simple majorities in both houses, they should be adopted through reconciliation. Then the House should pass the Senate bill."Read more here
The pursuit of health care reform is a manifestation -- indeed it is the ultimate mission of liberal elitists one on side of a culture war that James Q. Wilson characterized with regard to the national split over the Iraq war. That divide exists on healthcare. Wilson wrote of a "linkage between ideology, on the one hand, and congressional polarization, media influence, interest-group demands, and education on the other are easily read in the commentary surrounding the 2004 election. In their zeal to denigrate the president, liberals, pronounced one conservative pundit, had "gone quite around the twist." According to liberal spokesmen, conservatives with their "religious intolerance" and their determination to rewrite the Constitution had so befuddled their fellow Americans that a "great nation was felled by a poisonous nut."
If such wholesale slurs are not signs of polarization, then the word has no meaning. To a degree that we cannot precisely measure, and over issues that we cannot exactly list, polarization has seeped down into the public, where it has assumed the form of a culture war. The sociologist James Davison Hunter, who has written about this phenomenon in a mainly religious context, defines culture war as "political and social hostility rooted in different systems of moral understanding." Such conflicts, he writes, which can involve "fundamental ideas about who we are as Americans," are waged both across the religious/secular divide and within religions themselves, where those with an "orthodox" view of moral authority square off against those with a "progressive" view.
To some degree, this terminology is appropriate to today's political situation as well. We are indeed in a culture war in Mr. Hunter's sense, though I believe this war is itself but another component, or another symptom, of the larger ideological polarization that has us in its grip. Conservative thinking on political issues has religious roots, but it also has roots that are fully as secular as anything on the Left. By the same token, the liberal attack on conservatives derives in part from an explicitly "progressive" religious orientation--liberal Protestantism or Catholicism, or Reform Judaism--but in part from the same secular sources shared by many conservatives."
Wilson goes on to ask and answer:"But what, one might ask, is wrong with having well-defined parties arguing vigorously about the issues that matter? Is it possible that polarized politics is a good thing, encouraging sharp debate and clear positions? Perhaps that is true on those issues where reasonable compromises can be devised. But there are two limits to such an arrangement.
"....many Americans believe that unbridgeable political differences have prevented leaders from addressing the problems they were elected to address. As a result, distrust of government mounts, leading to an alienation from politics altogether. The steep decline in popular approval of our national officials has many causes, but surely one of them is that ordinary voters agree among themselves more than political elites agree with each other--and the elites are far more numerous than they once were."
Read more here
The misguided effort to push through the current health care bill will deepen the divide as well as the distrust. As Wilson notes, since they are so many elites (the so-called stakeholders and people like me who follow them with blogs, white papers and Hill briefings) the ability of government to serve as a connective tissue to public opinion is dampened. The push for health care is leading to an outright rejection of the very politicians themselves. But importantly it is not leading to the alienation from politics. It is fueling an awakening.
Read more here
It is largely invented and based on the skewed interpetation of the authors who want us to believe that their misleading and sloppy scholarship is less lethal than smoking. I am not sure myself and I hate smoking…
Here are the conclusions three of the studies they used to make this sweeping conclusion:
A thoughtful and provocative piece by Matt Herper over at Forbes.
FDA Agreement Should Be Public
One of the biggest initiatives Margaret Hamburg has announced since she became head of the Food and Drug Administration is a new push to make FDA's doings more transparent to the outside world. Yesterday's bad news for Seattle-based Cell Therapeutics represents one way in which the regulator fails to make sure investors have information they need.
Cell Therapeutics (CTI) shares fell 40% to 60 cents yesterday after an briefing document prepared by the FDA raised multiple problems with the company's drug, pixantrone, and the quality of the clinical trials Cell Therapeutics is using to argue for its approval as a treatment for non-Hodgkin's Lymphoma. The biggest shocker, though, related to an agreement called a "special protocol assessment" which the company had told investors it had but which the FDA now says is no longer valid.
Special protocol assesments, or SPAs, are important for every drug company, from the tiniest fleaspeck biotechnology company all the way up to Pfizer. They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved. This reassures companies that they are not going to pour $40 million into a late-stage study only to have the FDA say it did the wrong trial. SPAs also ease investor fears, helping smaller companies raise money.
Unfortunately, they are treated by FDA as confidential communications between the agency and companies. What is said to investors about the SPA is entirely up the the company. Between March 28, 2008, and September 16 2009, CTI reference the SPA in five press releases. But in the briefing documents released yesterday, the FDA stated: "On March 28, 2008, CTI notified the FDA of an early halt to enrollment for PIX301. The study was not stopped at a planned interim analysis and early study stopping invalidated the applicant’s Special Protocol Assessment." A CTI spokesman did not comment when asked why investors were not informed of this change.
This is not the first time this sort of thing has happened. In 2008, it was revealed at an FDA advisory committee meeting that GPC Biotech had misrepresented the SPA for its prostate cancer drug, causing shares to drop 60% in a day.
It might take an act of Congress to allow the FDA to make SPAs public, but that should happen. This would increase their value to biotechnology firms who are trying to raise money and prevent run-of-the-mill stock buyers from getting fleeced.
EJ Dionne the doyen of liberal lecturing down to the masses explains -- through a charming parable told to him by a member of Congress -- why it is ok for Democrats to ram through the current health bill -- Cornhusker kickback and all: because we the dumb schmucks are too stupid to understand what's good for us until it is put in front of us in the fashion liberals have established:
"On health care: 'Finish the kitchen'
By E.J. Dionne Jr.
Monday, February 8, 2010; A15
If President Obama gets to sign a health-reform bill, as I believe he will, one reason may be Rep. Jay Inslee's difficult experience renovating his kitchen.
He told his kitchen story at a House Democratic caucus after Republican Scott Brown's victory in Massachusetts sent Inslee's colleagues into paroxysms of dismay, chaos and fear. Brown's triumph reduced the Democrats' majority in the Senate to "only" 59, and this led many in both houses to want to give up on health reform altogether. Even Obama was sounding an uncertain trumpet.
This made no sense to Inslee, a Democrat from Washington state. First elected to the House in 1992, he was swept out of office in the 1994 Republican landslide that followed the collapse of Bill Clinton's health-care efforts. Four years later, Inslee returned to Congress.
"I introduced myself as a fella who was defeated in 1994, the last time we didn't pass meaningful health-care reform," Inslee recalls saying. "I said it was a painful event, and I didn't want them to go through that pain." In politics, he told his colleagues, assuming the "fetal position" can be the most dangerous thing to do.
And then he recounted all the grief he and his family went through while work on their kitchen renovation dragged on and on and on. "During that time, I had blood lust against my contractor," Inslee said. "Six months went by, and he was still arguing with the plumber. Eight months went by, and there were still wires hanging down everywhere, and he was having trouble with the building inspector."
But eventually, the job got done. "And now I love that kitchen," Inslee recalls saying. "I bake bread in that kitchen. My wife cooks great meals in that kitchen. The contractor's now a buddy of mine, and I've had beers with him in that kitchen."
Inslee looked at his colleagues and declared: "We've got to finish the kitchen." His point was that Americans won't experience any of the benefits of health-care reform until Congress puts a new system in place.
I called Inslee about his kitchen oration after Rep. David Wu (D-Ore.) told me it was one of the turning points in calming Democrats' nerves. "Now," Wu says, "people run into him in the hallway, smile and say, 'Finish the kitchen.' "
Dionne is in LOVE with this analogy... I hope he and his fellow autocrats continue to spread the message.
Here's how is condescending disregard for the public sounds to the rest of us simple folk:
"Some paradox of our natures leads us, when once we have made our fellow men the objects of our enlightened interest, to go on to make them the objects of our pity, then of our wisdom, ultimately of our coercion. " Lionel Trilling, The LIberal Imagination (1950)
Apart from the dangerous and bizaare indulgence of the whims of anti-vaccine and anti-science groups, AHRQ's role in developing studies and evidence standards for use of personalized medicine, targeted therapies, nanotechnology, drug/diagnostic combinations, etc.. (studies conducted by a small group of organizations that include those controlled by HMOs who also control the funding decisons made by AHRQ) for HMOs, Medicare, Medicaid, etc will impose significant costs on innovation and well-being.
Most recently the FDA approved the use of Crestor as a preventive treatment for heart disease using hsCRP tests to identify those specific patients who might benefit. Clearly a step towards targeted and prudent use of statins. Women were found to benefit more than men from early intervention. Yet ARHQ's recommendation to the US Preventive Services Task Force was to NOT use hsCRP tests in primary care settings until there were more randomized trials..
Continuing to impose the barrier of randomized trials on all new individualized technologies is tantamount to creating Jim Crow laws for personalized medicine. And indeed, the impact of using expensive randomized trials to test everything new will be to make fewer new things available without knowing which are valuable to who.
Which is the point of bending the curve: slowing consumption of new technologies across the board to free up money for bigger entitlements. Unfortunately, the use of older and cheaper more often does not translate into better health and lower costs.
Republicans and Democrats who truly want a serious American effort to improve health care should shun the White House offer of media exposure and concentrate on getting better information on what my colleague Peter Pitts calls the four health care rights of the 21st century: the right medicine for the right person for the right reason at the right time. Such rights increase wellbeing and improve value. Scrapping AHRQ's agenda and conflicted approach to pursuing it is the first step in that healthy direction
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
